UK MPs demand more stringent regulation of medical devices across EuropeBMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e7350 (Published 31 October 2012) Cite this as: BMJ 2012;345:e7350
- Ingrid Torjesen
European Union regulations on the safety of medical implants must be tightened urgently to prevent manufacturers from seeking approval for devices in member states where the regulations are most lax, a report by a committee of MPs has found.
Once approval has been granted in one member state, the device can be used throughout Europe, regardless of the laxity of the approval process in the chosen member state.
Recent recalls of certain devices, such as metal-on-metal hip replacements and the faulty Poly Implant Prosthèse (PIP) breast implants,1 2 have also highlighted the need for manufacturers and regulators to be compelled to publish much more rigorous clinical data on the safety of new implants and to be subject to greater scrutiny, says the report from the Science and Technology Committee, published …